|Publication number||US8989866 B2|
|Application number||US 14/029,606|
|Publication date||24 Mar 2015|
|Filing date||17 Sep 2013|
|Priority date||7 Oct 2004|
|Also published as||EP1804660A2, EP1804660A4, US8538539, US20090018610, US20140148796, WO2006042075A2, WO2006042075A3|
|Publication number||029606, 14029606, US 8989866 B2, US 8989866B2, US-B2-8989866, US8989866 B2, US8989866B2|
|Inventors||James E. Gharib, Allen Farquhar, Kelli Howell, Doug Layman, Albert Pothier|
|Original Assignee||Nuvasive, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (58), Non-Patent Citations (8), Classifications (26), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of U.S. patent application Ser. No. 11/665,038 filed Apr. 9, 2007 (now issued as U.S. Pat. No. 8,538,539), which was the national state entry of PCT/US05/36089, filed on Oct. 7, 2005, which claims priority to U.S. Provisional Patent Application Ser. No. 60/617,142 filed on Oct. 7, 2004, U.S. Provisional Patent Application Ser. No. 60/622,494 filed on Oct. 26, 2004, and U.S. Provisional Patent Application Ser. No. 60/721,424 filed on Sep. 27, 2005, the entire contents of which are hereby expressly incorporated by reference into this disclosure as if set forth in their entirety herein.
I. Field of the Invention
The present invention relates generally to a system and methods aimed at surgery, and more particularly to system and methods for testing the neuromuscular blockade level in a patient prior to conducting nerve tests aimed at detecting pedicle breaches, nerve proximity, nerve direction, and nerve pathology.
II. Discussion of the Prior Art
Despite ongoing advances in surgical methods, neurological impairment remains a serious concern during various surgical spine procedures. The misplacement of a pedicle screw or inadvertent contact between a surgical instrument and nerve during surgery may result in undesirable consequences, including pain, necessitation of revision surgeries, nerve damage, and a possible loss of muscle function. To avert such consequences, surgeons are increasingly relying on systems and methods that capitalize on the knowledge that electrically stimulating a nerve should result in detectable muscle activity.
While these existing EMG systems are significant advancements within the art, proliferated use of neuromuscular blocking agents (muscle relaxants) during surgery present certain challenges with the use of these systems. More specifically, surgeons must wait for a period of time to allow the neuromuscular blocking agents (NMBA) to wear off before initiating a nerve test, which increases surgery time and overall cost. NMBAs generally inhibit the neuromuscular pathway by binding to acetylcholine receptors on the postsynaptic membrane and hence, decrease neuromuscular transmission (transfer of a motor nerve impulse into the muscle) relative to the number of receptors occupied at a given time. This inhibition of the neuromuscular pathway is commonly referred to as neuromuscular block or blockade (NMB). If the neuromuscular pathway is sufficiently blocked, stimulation of a nerve will not result in the otherwise expected contraction of the corresponding muscle. NMB is a necessity during many surgical procedures in order to maintain a certain level of muscle relaxation, however, as mentioned it requires the surgeon to wait for the NMB to wear off prior to initiating a nerve test. If the nerve test is conducted too soon the muscle may fail to contract upon stimulation of the nerve and the stimulation current level at which the nerve is stimulated will appear to be higher than it truly is. This may create, in effect, a false positive wherein the surgeon may believe, for example, a pedicle wall has not been breached or a nerve farther from an instrument than it really is because of the erroneously high stimulation level detected.
The amount and metabolic rate of NMBA may vary from procedure to procedure and person to person. In addition, the present systems retain their effectiveness up to a certain level of NMB. Together this makes it difficult to determine when precisely nerve testing functions regain their effectiveness and surgeons must wait longer than necessary to ensure accurate results, which results in additional surgical time and increased costs. Being able to assess the neuromuscular pathway prior to initiating nerve testing would reduce the amount of waiting time needed and would thus represent a savings in time and costs to both the surgeon and patient.
Neuromuscular pathway testing is currently performed by specialists (neurophysiologists) trained in assessing the neurophysiologic information graphically represented on traditional EMG systems. While these individuals are oftentimes exceptionally skilled and highly trained, there exists the potential for human error on their part in reading and/or monitoring such traditional EMG systems. Moreover, the need for the neurophysiologist to assist in a surgical case adds complexity and challenges in scheduling surgical procedures, in that the schedules of both individuals need to coincide for them to work together. This may disadvantageously cause a patient to wait, while experiencing pain and/or other issues, for the scheduling conflicts of the surgeon and neurophysiologist to resolve. Because the neurophysiologist performs the actual neuromuscular pathway testing, there exists the potential for communication gaps to occur between the surgeon and the neurophysiologist such that the neuromuscular testing may not be conducted as desired by the surgeon. Also, with the attendant activity in the operating room (as well as other operating rooms where the neurophysiologist may be working), the possibility exists that the neuromuscular pathway testing may not be conducted in the desired manner based on inattentiveness of the neurophysiologist.
Based on the foregoing, a need exists for improved systems and methods for surgeon-directed nerve testing during surgery, and in particular a need exits for improved systems and methods for combining neuromuscular pathway assessment and nerve testing capabilities, all being performed by the surgeon. The present invention is directed towards fulfilling these needs.
The present invention includes a system and related methods for assessing the state of the neuromuscular pathway prior to and in combination with performing nerve testing functions aimed at detecting pedicle breaches during screw implantation, nerve proximity to surgical instruments employed in accessing a surgical target site, and nerve pathology monitoring. Advantageously, the system and methods of the present invention are surgeon-directed, meaning the surgeon is capable of directing all such functionality without the need for a neurophysiologist.
According to a broad aspect, the present invention involves a surgeon-directed surgical system, comprising a control unit, a surgical instrument, and peripheral nerve stimulation electrodes. The control unit has at least one of computer programming software, firmware and hardware capable of delivering a stimulation signal, receiving and processing neuromuscular responses due to the stimulation signal, and identifying a relationship between the neuromuscular response and the stimulation signal. The surgical instrument has at least one stimulation electrode electrically coupled to the control unit for transmitting a stimulation signal within a surgical corridor. Peripheral nerve stimulation electrodes are also coupled to the control unit for transmitting a stimulation signal to peripheral nerves outside a surgical corridor. The control unit is capable of determining the neuromuscular blockade level and at least one of pedicle integrity, nerve proximity, nerve direction, and nerve pathology based on the identified relationship between a stimulation signal and a corresponding neuromuscular response.
In a further embodiment of the surgical system of the present invention, the control unit is further equipped to communicate at least one of alpha-numeric and graphical information to a user regarding neuromuscular pathway status, and at least one of pedicle integrity, nerve proximity, nerve direction, and nerve pathology.
In a further embodiment of the surgical system of the present invention, the surgical instrument may comprise at least one of a device for testing screw placement integrity, a device for accessing a surgical target site, and a device for maintaining contact with a nerve during surgery.
In a further embodiment of the surgical system of the present invention, the surgical instrument comprises a screw test probe and wherein the control unit determines the degree of electrical communication between the screw test probe and an exiting spinal nerve root to assess whether a pedicle has been breached by at least one of hole formation and screw placement
In a further embodiment of the surgical system of the present invention, the surgical instrument comprises a nerve root retractor and wherein the control unit determines nerve pathology based on the identified relationship between the neuromuscular response and the stimulation signal.
In a further embodiment of the surgical system of the present invention, the surgical instrument comprises a dilating instrument and wherein the control unit determines the proximity and direction between a nerve and the instrument based on the identified relationship between the neuromuscular response and the stimulation signal.
In a further embodiment of the surgical system of the present invention, the dilating instrument comprises at least one of a K-wire, an obturator, a dilating cannula, and a working cannula.
In a further embodiment of the surgical system of the present invention, the surgical instrument comprises a tissue retractor assembly and wherein the control unit determines the proximity between a nerve and the instrument based on the identified relationship between the neuromuscular response and the stimulation signal.
Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:
Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The systems disclosed herein boast a variety of inventive features and components that warrant patent protection, both individually and in combination.
The present invention involves a surgeon-directed system and methods for assessing the neuromuscular pathway prior to and in combination with nerve testing procedures during surgery, including but not limited to pedicle integrity assessments (screw test), nerve proximity assessments (direction), and nerve pathology assessments (nerve root retraction).
The surgeon-directed surgical system 10 includes a control unit 12, a patient module 14, an EMG harness 16 (including eight pairs of EMG electrodes 18 and a return electrode 22 coupled to the patient module 14), and a host of various surgical accessories 32 capable of being coupled to the patient module 14 via one or more accessory cables 30 and/or coupling devices 42. The surgical accessories 32 may include, but are not necessarily limited to, devices for performing pedicle screw tests (such as a screw test probe 36), neural pathology monitoring devices (such as a nerve root retractor 76), coupling devices for electronically coupling surgical instruments to the system 10 (such as electric coupling devices 42,52 and stimulator driver 68), access components (such as a K-wire 62, one or more dilating cannula 64, a working cannula 66, and a tissue retraction assembly 70), and pilot hole forming components (such as a tap member 72, pedicle access probe 74, or other similar device), and devices for delivering peripheral stimulation signals (such as a pair—one positive and one negative—of peripheral nerve stimulation (PNS) electrodes 25).
A block diagram of the surgical system 10 is shown in
The patient module 14 is connected via a data cable 28 to the control unit 12, and contains the electrical connections to all electrodes, signal conditioning circuitry, stimulator drive and steering circuitry, and a digital communications interface to the control unit 12. In use, the control unit 12 is situated outside but close to the surgical field (such as on a cart adjacent the operating table) such that the display 26 is directed towards the surgeon for easy visualization. The patient module 14 should be located between the patient's legs or affixed to the end of the operating table at mid-leg level using a bedrail clamp. The position selected should be such that the EMG electrodes 18 can reach their farthest desired location without tension during the surgical procedure.
In a significant aspect of the present invention, the information displayed to the surgeon on the display 26 may include, but is not necessarily limited to, alpha-numeric and/or graphical information regarding NMP status, screw testing, nerve proximity, nerve pathology, myotome/EMG levels, stimulation levels, advance or hold instructions, and the instrument in use. In one embodiment (set forth by way of example only) the display includes the following components as set forth in Table 1:
Spine Image 100
An image of the human body/skeleton showing the electrode
placement on the body, with labeled channel number tabs on each
side (1-4 on the left and right). Left and right labels will show the
patient orientation. The channel number tabs may be highlighted
or colored depending on the specific function being performed.
Myotome & Level
A label to indicate the Myotome name and corresponding Spinal
Level(s) associated with the channel of interest.
A drop down navigation component for toggling between
Display Area 106
Shows procedure-specific information including stimulation results
Color Indication 108
Enhances stimulation results with a color display of green, yellow,
or red corresponding to the relative safety level determined by the
system. In one embodiment, “Advance” or “Hold” instructions
may be optionally displayed also corresponding to the relative
safety level determined by the system in the Detection mode.
Graphics and/or name to indicate the currently active function
(Twitch Test, Basic Screw Test, Dynamic Screw Test, Difference
Screw Test, Detection, Nerve Retractor). In an alternate
embodiment, Graphics and/or name may also be displayed to
indicate the instrument in use, such as the dialator, K-wire,
retractor blades, screw test instruments, and associated size
information (if applicable) of the dilator, with the numeric size. If
no instrument is in use, then no indicator is displayed.
Stimulation Bar 112
A graphical stimulation indicator depicting the present stimulation
status (e.g. on/off and stimulation current level)
Sequence Bar 114
Shows the last seven stimulation results and provides for
annotation of results.
EMG waveforms may be optionally displayed on screen along with
the stimulation results.
Switching between the various functions of the surgical system 10 may be accomplished from a drop down menu 104, which is preferably accessible from all screens on the GUI display 26. Selecting the menu button 118 labeled, by way of example only, “Select Mode” expands the drop down menu 104 as seen in
A setup mode provides a simple means for selecting and/or changing various options and parameters associated with the functions of the surgical system 10. A setup tab 124 is provided on the GUI display 26 for accessing the setup mode, which preferably includes a separate setup screen for each function.
In a preferred embodiment, the surgeon-directed surgical system 10 detects and monitors muscle activity using EMG (electromyogram). EMG monitoring is preferably carried out utilizing the same equipment and configuration for all the functions of the surgical system 10 and will now be described. EMG response monitoring is accomplished via 8 pairs of EMG electrodes 18 placed on the skin over the major muscle groups of the legs (four per side), a common electrode 20 providing a ground reference to pre-amplifiers in the patient module 14, and an anode electrode 20 providing a return path for the stimulation current. The EMG responses provide a quantitative measure of the nerve depolarization caused by the electrical stimulus. Depending on the particular function, analysis of the EMG responses is used to determine the status of the neuromuscular pathway (NMP), pedicle integrity, nerve proximity or nerve pathology. If peripheral nerve stimulation is chosen for the NMP test according to the present invention, it is preferably targeted to a nerve innervating one of the muscle groups to be monitored during the ensuing nerve tests. In doing so, one pair of EMG electrodes 18 is utilized during both NMP testing and the desired nerve testing, thereby eliminating the need for additional electrodes and recording channels. By way of example only, the placement of EMG electrodes 18 for spinal surgery may be undertaken according to the manner described in Table 2 below:
Right Vastus Medialis
L2, L3, L4
Right Biceps Femoris
L5, S1, S2
Right Gastroc. Medial
Left Vastus Medialis
L2, L3, L4
Left Tibialis Anterior
Left Biceps Femoris
L5, S1, S2
Left Gastroc. Medial
Although not shown, it will be appreciated that any of a variety of electrodes can be employed, including but not limited to surface pad electrodes and needle electrodes. It should also be appreciated that EMG electrode placement has been shown and described, by way of example only, as it relates to use of the surgical system 10 during procedures in the lumbar spine. However, electrode placement depends on the surgical area and particular nerves at risk, and as such is not limited to the legs. By way of example, the surgical system 10 and its various functions may be utilized in the cervical and thoracic regions as well, wherein, it may be necessary to deploy the EMG electrodes 18 on the upper or mid regions of the body, respectively.
The surgical system 10 may perform NMP assessments by electrically stimulating a peripheral nerve via PNS electrodes 25 placed on the skin over the nerve and/or by direct stimulation of a spinal nerve using a surgical accessory such as screw test probe 36. Evoked responses from the muscles innervated by the stimulated nerve are detected and recorded, the results of which are analyzed and a relationship between at least two responses or a stimulation signal and a response is identified. The identified relationship provides an indication of the status of the NMP (e.g. blocked, unblocked, questionable). As discussed in greater detail below, the identified relationship may include, but is not necessarily limited to, one or more of magnitude ratios between multiple evoked responses and/or the presence or absence of an evoked response relative to a given stimulation signal or signals. Details of the test indicating NMP status and the relative safety of continuing on with nerve testing are conveyed to the surgeon via the screen display 26.
According to one embodiment of the present invention, NMP testing may be carried out utilizing direct stimulation and/or peripheral stimulation. The decision to use the Direct or Peripheral Stimulation modes should be based on the particular needs, experience, and preferences of the operating surgeon. Choosing between the modes is preferably accomplished on the GUI display 26 from the Twitch Test setup screen, illustrated in
In one embodiment of the present invention, the stimulation pulses of the NMP test may be delivered at a supramaximal current, such that all the muscle fibers of the given muscle contract and the force of contraction is at its maximum level (in the absence of NMB). The level of current required to achieve a supramaximal effect varies between individual patients. Several factors including fluctuations in skin resistivity during a procedure, fat content, muscle mass, and muscle contractility, all may affect the current level necessary to achieve a supramaximal effect. Likewise, the voltage required to maintain the supramaximal current at the same level varies in response to the variations in resistance based on these factors. In one embodiment the surgical system 10 therefore determines an optimum current (hereinafter referred to as the “baseline current”) to be used for each individual patient. In addition, the current output may be continually monitored and the voltage output adjusted so as to maintain the selected baseline current throughout the test.
In another embodiment, the baseline current used for the NMP test may be such that it is slightly larger than the threshold current level (IThresh) at the time the NMP test is conducted. Ithresh is the lowest stimulation current necessary to evoke an EMG response with a peak-to-peak voltage (Vpp) greater than a predefined threshold voltage (Vthresh) which is typically around 100 μV. To determine the stimulation current level to employ for the NMP test, the surgical system 10 may use a threshold-hunting algorithm to quickly and accurately find Ithresh. Preferably, upon selecting the Auto Detect tab 128, the system 10 detects Ithresh using a threshold-hunting algorithm that applies bracketing and bisection methods which are described in detail below. Once Ithresh has been determined the surgical system 10 may display Ithresh for the user and/or select a baseline current that is greater than Ithresh, which may similarly be displayed for the surgeon. According to one embodiment, set forth by way of example only, this baseline current determination may be accomplished by adding at least 1.0 mA to Ithresh.
After setting a baseline current, the baseline current may subsequently be used any time the NMP test is conducted during a surgical procedure (i.e. prior to initiating the nerve monitoring tests, discussed in detail below) or a new baseline may be determined each time. As previously mentioned, an exemplary NMP test consists of four 200 μs electrical impulses, delivered at a frequency of 2 Hz and at the determined baseline current. When the test is completed in the presence of little or no NMB, the muscle activity pattern contains four clearly defined muscle contractions of approximately the same amplitude, illustrated, by way of example only, in
According to one embodiment of the present invention, the surgeon-directed surgical system 10 identifies a ratiometric relationship between evoked responses to assess the status of the NMP. The amplitudes of each EMG response corresponding to the four electrical pulses (described above with reference to
Although use of the system 10 for neuromuscular pathway assessment is shown and described above within the context of particular exemplary method of stimulation response analysis, it will be appreciated by those skilled in the art that a variety of methods may be employed by the system 10, for stimulating a nerve and analyzing the resultant muscle response or responses in order to determine the state of the neuromuscular pathway, and as such, fall within the scope of the present invention. These methods may include, but are not necessarily limited to the all-or-none and single twitch techniques described below.
In an alternate embodiment, the disappearance of each response corresponds to particular level of NMB. By way of example only, the fourth contraction disappears at a 75% NMB level (meaning that 75% of the acetylcholine receptors are occupied), the third contraction disappears at 80% NMB (meaning that 80% of the acetylcholine receptors are occupied), the second disappears at 90% NMB (meaning that 90% of the acetylcholine receptors are occupied), and the first contraction disappears at 100% NMB level (meaning that 100% of the acetylcholine receptors are occupied). In one embodiment of the present invention, detection of an NMB level greater than 75%, (i.e. less than four contractions detected, corresponding to the four electrical impulses) as depicted in
In still another embodiment, the surgeon-directed surgical system 10 may employ a “single twitch” method for assessing the neuromuscular pathway. A baseline supramaximal current is again determined by the method set forth and described above. After determining the baseline and still prior to the administration of NMB, a single 100 μs-300 μs (preferably 200 μs) electrical pulse of the baseline current is delivered to the patient via the surgical system 10 and the muscle response is measured. The amplitude of the measured response is the control value or T0 for subsequent NMP tests. NMP tests are later initiated in the selected mode (Direct or Peripheral stimulation) with a single electrical impulse identical to the pulse used to obtain T0 and the evoked muscle response is measured. The measured amplitude of the response becomes T1. The system 10 calculates the amplitude ratio between T0 and T1 (T1:T0) and compares it to predetermined safe and unsafe levels. By way of example only, when T1:T0 is greater than or equal to 0.9 (T1:T0≧0.9) the NMP test is acceptable and the display 26 indicates the safe result. When the T1:T0 ratio is less than 0.9 (T1:T0<0.9) the NMP is determined to unsafe (blocked) and the result is again indicated on the display 26, thereby alerting the surgeon to the unsafe NMP status.
While the NMP function has been described according to a preferred embodiment in which evoked muscle responses are detected using EMG, it is contemplated that other methods of detecting and measuring evoked responses may also be employed. In an alternate embodiment, set forth by way of example only, the surgical system 10 may use pressure sensors (not shown) communicatively linked to the system, to monitor muscle activity. An increase in pressure detected by the pressure sensors deployed over various muscles or myotomes indicates a muscle response. The magnitude of the response is reflected by the degree of pressure change detected. The evoked responses may then be analyzed to identify a relationship between them according to one or more of the methods described above thereby providing an indication of the NMP status.
The surgeon-directed surgical system 10 is capable of performing pedicle integrity tests, preferably after an NMP test has been conducted and deemed acceptable and safe. This functionality includes a “Basic” screw test and a “Dynamic Screw Test.” The basic, or static, screw test function is performing using screw test probe 36. The screw test probe 36 is used to test the integrity of pedicle holes (during and/or after formation) and/or screws (during and/or after introduction). The screw test probe 36 includes a stimulation handpiece 34 and a probe member 38 having a generally ball-tipped end 40. The handpiece 34 may be equipped with one or more buttons for selectively applying the electrical stimulation to the ball-tipped end 40 at the end of the probe member 38. The ball tip 40 of the screw test probe 36 is placed in the screw hole prior to screw insertion or placed on the installed screw head. The insulating character of bone will prevent the stimulation current, up to a certain amplitude, from communicating with the nerve. However, in the event the pedicle wall has been breached by the screw or tap, the stimulation current will pass through to the adjacent nerve roots and they will depolarize at a lower stimulation current.
The “Dynamic” screw test function may use at least one of an electric coupling device 42 and 52. The probe member 38 and the ball-tipped end 40 of screw test probe 36 may be removed from the stimulation handpiece 34 and replaced with an electric coupling device 42, 52. The electric coupling devices 42, 52 may be utilized to couple a surgical instrument, such as for example only, a tap member 72, pedicle access probe 74, or other similar instrument, to the surgical system 10. By this means, a stimulation signal may be passed through the surgical instrument and screw testing can be performed while the tool is in use. Thus, screw testing may be performed during pilot hole formation by coupling the tap member 72 or pedicle probe 74 to the surgical system 10. Likewise, by coupling a pedicle screw to the surgical system 10, screw testing may be performed during screw introduction.
The electric coupling device may comprise a number of possible embodiments which permit the device to attach and hold a surgical instrument while allowing transmission of a stimulation signal to the tool. One such electric coupling device 42 utilizes a spring-loaded plunger to hold the surgical tool and transmit the stimulation signal. The plunger 44 is composed of a conductive material such as metal. A nonconductive housing 46 partially encases the plunger 44 about its center. Extending from the housing 46 is an end plate 48. An electrical cable 50 connects the electric coupling device 42 to the stimulation handpiece 34. A spring (not shown) is disposed within the housing 46 such that in a natural or “closed” state the plunger 44 is situated in close proximity to the endplate 42. Exerting a compressive force on the spring (such as by pulling the cable 50 while holding the housing 46) causes a gap between the end plate 48 and the plunger 44 to widen to an “open” position, thereby allowing insertion of a surgical tool between the end plate 48 and plunger 44. Releasing the cable 50 allows the spring to return to a “closed” position, causing the plunger 44 to move laterally back towards the endplate such that a force is exerted upon the surgical instrument and thereby holds it in place between the endplate 48 and the plunger 44. Thereafter the electrical stimulus may be passed from the handpiece 34 through the cable 50 and plunger 44 to the surgical instrument.
Alternatively, the electrical coupling device may be embodied in the form of a clip 52. The clip 52 is comprised of two prongs hingedly coupled at a coupling point 54 such that the clip 52 includes an attachment end 56 and a non-attachment end 58. A stimulation electrode 60 is disposed on the attachment end 56 and communicates with electric cable 50 extending from the non-attachment end 56 to the handle 34. In a “closed” position the prong ends at the attachment end 56 touch. Depressing the prongs at the non-attachment end 58 in a direction towards each other causes a gap to form between the prong ends at the attachment end 56. Positioning the “opened” attachment end 56 over a desired surgical instrument and releasing the force on the non-attachment end 58 causes the attachment end 56 to pinch tight on the surgical instrument and thereby allow the electrical stimulus to pass from the screw test handle 34, through the stimulation electrode 60, to the surgical instrument.
Upon pressing the button on the stimulation handpiece 34, the software will execute an algorithm (discussed below) that results in all channel tabs 132 being color-coded to indicate the detection status of the corresponding nerve. The algorithm preferably determines the depolarization (stimulation threshold current, Ithresh) current for all 8 EMG channels. The channel with the “worst” (lowest Ithresh) level will be highlighted (enlarged) and that myotome name will be displayed 102, as well as graphically depicted on the spine diagram 100 and the numerical stimulation result (Ithresh) 120 for that channel is displayed, as illustrated in
The surgeon-directed surgical system 10 may provide safe and reproducible access to a surgical target site by detecting the existence of (and optionally the distance) neural structures before, during, and after the establishment of an operative corridor through (or near) any of a variety of tissues having such neural structures which, if contacted or impinged, may otherwise result in neural impairment for the patient. The surgical system 10 does so, preferably after an acceptable NMP test has been completed, by electrically stimulating nerves via one or more stimulation electrodes at the distal end of the surgical access components 62-66 while monitoring the EMG responses of the muscle groups innervated by the nerves. In a preferred embodiment the access components are coupled to the surgical system 10 using electrical coupling device 42 or 52 in the same manner described above. Alternatively, a stimulator driver 68 is provided to electrically couple the surgical access components 62-66 to the patient module 14 (via accessory cable 30). The stimulator driver 68 preferably includes one or more buttons for selectively activating the stimulation current and/or directing it to a particular surgical access component.
The surgical access components 62-66 (
Additional and/or alternative surgical access components such as, by way of example only, a tissue retraction assembly 70 (
The surgical system 10 accomplishes neural pathology monitoring, preferably after conducting a neuromuscular pathway test, by electrically stimulating a retracted nerve root via one or more stimulation electrodes at the distal end of the nerve root retractor 76 while monitoring the EMG responses of the muscle group innervated by the particular nerve. The EMG responses provide a quantitative measure of the nerve depolarization caused by the electrical stimulus. Analysis of the EMG responses may then be used to assess the degree to which retraction of a nerve or neural structure affects the nerve function over time, as will be described with greater particularity below. One advantage of such monitoring, by way of example only, is that the conduction of the nerve may be monitored during the procedure to determine whether the neurophysiology and/or function of the nerve changes (for the better or worse) as the result of the particular surgical procedure. For example, it may be observed that the nerve conduction increases as the result of the operation, indicating that the previously inhibited nerve has been positively affected by the operation. The nerve root retractor 76 (
In a preferred embodiment, nerve pathology is monitored via the Nerve Retractor function specifically by determining a baseline stimulation threshold with direct contact between the nerve retractor 76 and the nerve but prior to retraction. Subsequently, additional stimulation thresholds are determined during retraction and they are compared to the baseline threshold. Significant changes in the stimulation threshold may indicate potential trauma to the nerve caused by the retraction. The information regarding nerve pathology is conveyed to the surgeon via the nerve retractor screen display, shown by way of example only in
The nerve testing functions mentioned above (screw test, nerve proximity, nerve pathology) are based on assessing the evoked response of the various muscles myotomes monitored by the surgical system 10, preferably via the EMG electrodes 18. This is best shown in
A basic premise behind the neurophysiology employed for nerve testing in the present invention is that each nerve has a characteristic threshold current level (IThresh) at which it will depolarize. Below this threshold, current stimulation will not evoke a significant EMG response (Vpp). Consequently, it is this premise that makes NMP testing a valuable step in nerve testing because Ithresh may be significantly altered in the presence of high levels of NMB. Once the stimulation threshold (IThresh) is reached, the evoked response is reproducible and increases with increasing stimulation until saturation is reached as shown in
In order to obtain Ithresh and take advantage of the useful information it provides, the peak-to-peak voltage (Vpp) of each EMG response corresponding a given stimulation current (IStim) must be identified. This may be complicated by the existence of stimulation and/or noise artifacts which may create an erroneous Vpp measurement of the electrically evoked EMG response. To overcome this challenge, the surgical system 10 of the present invention may employ any number of suitable artifact rejection techniques such as those shown and described in full in the above referenced PCT App. Ser. No. PCT/US2004/025550, entitled “System and Methods for Performing Dynamic Pedicle Integrity Assessments,” filed on Aug. 5, 2004, the contents of which are hereby incorporated by reference into this disclosure as if set forth herein in their entireties.
Having measured each Vpp EMG response, the Vpp information is analyzed relative to the stimulation current in order to determine a relationship between the nerve and the given stimulation element transmitting the stimulation current. More specifically, the present invention determines these relationships (between nerve and the stimulation element) by identifying the minimum stimulation current (Ithresh) capable of resulting in a predetermined Vpp EMG response. According to the present invention, the determination of IThresh may be accomplished via any of a variety of suitable algorithms or techniques.
The threshold hunting will support three states: bracketing, bisection, and monitoring. A stimulation current bracket is a range of stimulation currents that bracket the stimulation current threshold IThresh. The upper and/or lower boundaries of a bracket may be indeterminate. The width of a bracket is the upper boundary value minus the lower boundary value. If the stimulation current threshold IThresh of a channel exceeds the maximum stimulation current, that threshold is considered out-of-range. During the bracketing state, threshold hunting will employ the method below to select stimulation currents and identify stimulation current brackets for each EMG channel in range.
The method for finding the minimum stimulation current uses the methods of bracketing and bisection. The “root” is identified for a function that has the value −1 for stimulation currents that do not evoke adequate response; the function has the value +1 for stimulation currents that evoke a response. The root occurs when the function jumps from −1 to +1 as stimulation current is increased: the function never has the value of precisely zero. The root will not be known precisely, but only with some level of accuracy. The root is found by identifying a range that must contain the root. The upper bound of this range is the lowest stimulation current IThresh where the function returns the value +1 (i.e. the minimum stimulation current that evokes response).
Both the screw test function and the proximity function, as well as the optional NMP baseline setting method utilizing Ithresh (described above), begin by adjusting the stimulation current from the surgical accessory until the root is bracketed (
During the bisection state (
During the monitoring state (
When it is necessary to determine the stimulation current thresholds (Ithresh) for more than one channel, they may be obtained by time-multiplexing the threshold-hunting algorithm as shown in
Insertion and advancement of the access instruments 62-66, 70 should be performed at a rate sufficiently slow to allow the surgical system 10 to provide real-time indication of the presence of nerves that may lie in the path of the tip. To facilitate this, the threshold current IThresh may be displayed such that it will indicate when the computation is finished and the data is accurate. For example, when the detection information is up to date and the instrument such that it is now ready to be advanced by the surgeon, it is contemplated to have the color display show up as saturated to communicate this fact to the surgeon. During advancement of the instrument, if a channel's color range changes from green to yellow, advancement should proceed more slowly, with careful observation of the detection level. If the channel color stays yellow or turns green after further advancement, it is a possible indication that the instrument tip has passed, and is moving farther away from the nerve. If after further advancement, however, the channel color turns red, then it is a possible indication that the instrument tip has moved closer to a nerve. At this point the display will show the value of the stimulation current threshold in mA. Further advancement should be attempted only with extreme caution, while observing the threshold values, and only if the surgeon deems it safe. If the surgeon decides to advance the instrument tip further, an increase in threshold value (e.g. from 3 mA to 4 mA) may indicate the instrument tip has safely passed the nerve. It may also be an indication that the instrument tip has encountered and is compressing the nerve. The latter may be detected by listening for sporadic outbursts, or “pops”, of nerve activity on a free running EMG audio output (as mentioned below). If, upon further advancement of the instrument, the alarm level decreases (e.g., from 4 mA to 3 mA), then it is very likely that the instrument tip is extremely close to the spinal nerve, and to avoid neural damage, extreme caution should be exercised during further manipulation of the instrument. Under such circumstances, the decision to withdraw, reposition, or otherwise maneuver the instrument is at the sole discretion of the clinician based upon available information and experience. Further radiographic imaging may be deemed appropriate to establish the best course of action.
As noted above, the surgical system 10 accomplishes neural pathology monitoring by electrically stimulating a retracted nerve root via one or more stimulation electrodes at the distal end of the nerve root retractor 76 while monitoring the EMG responses of the muscle group innervated by the particular nerve.
In addition to the directed nerve testing functions described above, the surgical system 10 also preferably performs passive monitoring via free run EMG conducted continuously from the EMG electrodes 18 when other functions are not active. In doing so, the operating user may be alerted to any nerve activity occurring unexpectedly. An audio pick-up (not shown) may also be provided as an optional feature according to the present invention. In some cases, when a nerve is stretched or compressed, it will emit a burst or train of spontaneous nerve activity. The audio pick-up is capable of transmitting sounds representative of such activity such that the surgeon can monitor this response on audio to help him determine if there has been stress to the nerve.
To facilitate record keeping, results from the various functions described above are preferably saved by the system 10 throughout the surgical procedure and a report may be generated containing all of the stimulation results. To enhance the clarity and usefulness of the reported data the surgical system 10 provides a method for quickly and easily annotating each stimulation result with additional relevant information including, but not necessarily limited to, the side and level where the stimulation occurred as well as the structure stimulated (e.g. nerve, screw, or pilot hole).
With reference to
The control unit 12 is configured to monitor the system status throughout its use. In the event the control unit 12 detects an aberration, an error log is created in which the details of the error are described and stored to assist in later troubleshooting and system correction. To service the system 10, the error logs may be accessed directly from the control unit 12 hardware and software. In addition, error logs may be downloaded onto any of a number of suitable media to facilitate data transfer between remote locations. By way of example only, the error logs may be downloaded to a USB memory device, floppy disk, CD, or DVD. By way of further example, the error logs may be downloaded onto a network and transmitted to remote locations via the Internet or other data transfer systems.
The surgeon-directed surgical system 10 of the present invention overcomes the drawbacks of the prior art and answers the previously unmet need in the prior art. The surgical system 10 boasts a number of techniques for performing neuromuscular pathway testing prior to nerve testing, such as pedicle integrity testing, nerve detection, and nerve pathology assessment, which advantageously minimizes the likelihood that the surgeon will obtain false positive assessments when performing such nerve testing procedures. Moreover, the surgical system 10 is capable of being controlled and interpreted by a surgeon without the assistance of a neurophysiologist (hence the term “surgeon-directed”). The complex task of EMG analysis is performed by the reliable and objective processing techniques of the present invention, which eliminates or at least reduces the potential for human error that is present with neurophysiologists. The surgeon-directed system 10 is quickly conveys the information in a straightforward and easy to understand (yet meaningful) manner, and does so under the command of the surgeon based on their immediate need (saving valuable surgery time). It also reduces the challenges involved in scheduling a neurophysiologist to assist with the surgery, as well as avoids the issue of making a patient wait (in pain) while the schedules of the surgeon and neurophysiologist coincide. Finally, the surgeon-directed system 10 combines the functional capability to perform nerve monitoring functions and the ability to ensure the safety and accuracy of those functions by assessing the neuromuscular pathway together in one easy to use, surgeon-directed system.
The surgical system 10 and related methods have been described above according to one embodiment of the present invention. It will be readily appreciated that various modifications may be undertaken, or certain steps or algorithms omitted or substituted, without departing from the scope of the present invention. By way of example only, certain of these alternate embodiments or methods will be described below. Moreover, although described with reference to the surgical system 10, it will particularly be appreciated as within the scope of the invention to perform the neuromuscular pathway test described herein with any number of different neurophysiology based testing systems.
While this invention has been described in terms of a best mode for achieving this invention's objectives, it will be appreciated by those skilled in the art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the present invention. For example, the present invention may be implemented using any combination of computer programming software, firmware or hardware. As a preparatory step to practicing the invention or constructing an apparatus according to the invention, the computer programming code (whether software or firmware) according to the invention will typically be stored in one or more machine readable storage mediums such as fixed (hard) drives, diskettes, optical disks, magnetic tape, semiconductor memories such as ROMs, PROMs, etc., thereby making an article of manufacture in accordance with the invention. The article of manufacture containing the computer programming code is used by either executing the code directly from the storage device, by copying the code from the storage device into another storage device such as a hard disk, RAM, etc. or by transmitting the code on a network for remote execution. As can be envisioned by one of skill in the art, many different combinations of the above may be used and accordingly the present invention is not limited by the specified scope.
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|U.S. Classification||607/48, 607/1, 607/2|
|International Classification||A61B5/04, A61B19/00, A61N1/04, A61B17/88, A61B5/0488, A61B5/00, A61B17/17, A61B17/02, A61B5/11, A61N1/00|
|Cooperative Classification||A61B5/04001, A61B90/06, A61B2505/05, A61B17/17, A61B5/6823, A61B2562/046, A61N1/0456, A61B5/0488, A61B17/02, A61B19/46, A61B5/4836, A61B17/8875, A61B5/1106|
|7 Feb 2014||AS||Assignment|
Owner name: NUVASIVE, INC., CALIFORNIA
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Effective date: 20070329
|16 Nov 2016||AS||Assignment|
Owner name: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT, CA
Free format text: NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS;ASSIGNORS:NUVASIVE, INC.;IMPULSE MONITORING, INC.;REEL/FRAME:040634/0404
Effective date: 20160208
|17 May 2017||AS||Assignment|
Owner name: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT, TE
Free format text: NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS;ASSIGNORS:NUVASIVE, INC.;BIOTRONIC NATIONAL, LLC;NUVASIVE CLINICAL SERVICES MONITORING, INC.;AND OTHERS;REEL/FRAME:042490/0236
Effective date: 20170425